All patients who participate in clinical trials are volunteers, and can choose to stop their involvement at any time.
Patients receive drugs or undergo procedures that have already been researched successfully in a laboratory and/or in animal studies. Some drugs and procedures have also already received approval by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA).
When conducting clinical trials, the researcher’s most important responsibility is to protect patients through well-designed protocols (plans), a dedicated Institutional Review Board (IRB) and a carefully informed consent process.
If your doctor offers you the option to participate in a clinical trial, you will first take part in a process called informed consent, to make sure that you understand the specific clinical trials’ plan to enable you to decide whether or not you want to be involved before agreeing to participate.
If you want to participate in a clinical trial after learning all that is involved and what you would be expected to do, then you will need to sign and date the informed consent form.
The informed consent process does not end once you sign the form. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants in the trial.